Integrative Care for Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Integrative Care for Type 2 Diabetes: Evaluating the Impact of Naturopathic Adjunctive Care for Diabetic Patients of a Family Health Team

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02843724
• Other study ID #: CanadianCNN
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: July 14, 2016
• Last updated: July 21, 2016
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: July 2016
• Source: The Canadian College of Naturopathic Medicine
• Contact: Ellen Wong, ND
• Phone: 416-498-1255
• Email: ewong[@]ccnm.edu
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

A two year, two arm pragmatic trial to investigate the integration of naturopathic care with conventional medical care to provide additional benefit beyond that of conventional medical care alone in achieving adequate control of diabetes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 148
• Est. completion date: July 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Males or females, enrolled as a patient with WE-FHT

• Ages 21-75 years old

• Diagnosed with type 2 diabetes and not adequately controlled (HbA1c > 7.0mmol/L)

• Currently seeking care with a medical doctor, nurse practitioner and/or physician assistant

• Willingness to adhere to randomized treatment with availability for follow-up

• Ability to answer self- and interviewer- administered questions in English or have an English speaking caregiver who can aid in answering self- and interviewer- administered questions

• Ability to provide written informed consent or give informed consent through substitute decision maker

• Capacity to maintain a diary and log of treatments and recommendations given during study

Exclusion Criteria:

• Lacking capacity for consent

• Pregnancy or an intention to become pregnant in the following two years

• Breastfeeding

• History of myocardial infarction within the past 6 months

• Chronic kidney (eGFR <30 mL/min) or liver disease

• Actively receiving care from a complex care diabetes clinic

• History of severe hypoglycemia in the last year resulting in hospital emergency care [where hypoglycemia is defined to be: 1) development of autonomic or neuroglycopenic symptoms, 2) low plasma glucose level (<4.0mmol/L for patients treated with insulin or an insulin secretagogue) and 3) symptoms responding to the administration of carbohydrate] or hypoglycemia unawareness

• Current bolus or pre-mixed insulin treatment

• Limited life expectancy (< 6 months)

• High level of functional dependency (inability to perform common activities of daily living)

• In participants aged 65yoa to 75yoa, the following also serve as exclusion criteria:

1. Recent MI or stroke (within last 6 months)

2. NYHA CHF Functional Capacity Stage III or above

3. NYHA CHF Objective Assessment Stage C or greater (http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure_UCM_306328_Article.jsp)

4. Planned revascularization procedure (PCI or coronary artery bypass graft) or coronary angiogram within 90 days after screening or randomization

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Naturopathic Care
Naturopathic diabetes care will be selected from a pre-approved menu. Participants' other health concerns will be addressed at naturopathic doctors' discretion
• Usual (Conventional) Care
2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented

Locations

Country	Name	City	State
Canada	Wise Elephant Family Health Team	Brampton	Ontario
Canada	The Canadian College of Naturopathic Medicine	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Canadian College of Naturopathic Medicine

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically meaningful reduction of HbA1c above and beyond that of control arm	To assess the integration of naturopathic care to conventional medical care in obtaining a clinically meaningful reduction of HbA1c (equal or > 0.5%) above and beyond reduction of HbA1c in the control group of phase 1 at 52 week for participants from Wise Elephant Family Health Team (WE-FHT) with type 2 diabetes	1 year	No
Secondary	Incidence of metabolic syndrome		2 year	No
Secondary	Weight (as part of BMI)	Kg	2 year	No
Secondary	Height (as part of BMI)	meters	2 year	No
Secondary	Waist circumference (as part of metabolic syndrome)	inches	2 year	No
Secondary	Fasting blood glucose	Fasting glucose (FG), biomarker associated with diabetes	2 year	No
Secondary	Glycated hemoglobin (HbA1c)	Biomarker associated with diabetes	2 year	No
Secondary	Blood pressure (BP)	Systolic and diastolic blood pressure, seated, resting	2 year	No
Secondary	Total cholesterol (TC) (blood)	Biomarkers associated with cholesterol & cardiovascular risk	2 year	No
Secondary	High-density lipoprotein (HDL-C) (blood)	Biomarkers associated with cholesterol & cardiovascular risk	2 year	No
Secondary	Low-density lipoprotein (LDL-C) (blood)	Biomarkers associated with cholesterol & cardiovascular risk	2 year	No
Secondary	Triglycerides (TG))(blood)	Biomarkers associated with cholesterol & cardiovascular risk	2 year	No
Secondary	High-sensitivity C-reactive protein (hs-CRP)	Biomarker associated with cardiovascular risk	2 year	No
Secondary	Incidence of smoking	Modifiable risk factors for cardiovascular disease	2 year	No
Secondary	Incidence of obesity	Modifiable risk factors for cardiovascular disease, BMI equal to or greater than 30.0 kg/m2	2 year	No
Secondary	Incidence of depression (PHQ-9)	Depression as defined by the PHQ-9	2 year	No
Secondary	Impact on stress, anxiety, quality of life	ADDQol	2 year	No
Secondary	Impact on anxiety	GAD 7	2 year	No
Secondary	DES	Impact on quality of life	2 year	No
Secondary	SF-12	Impact on quality of life	2 year	No
Secondary	Compliance/adherence with treatment prescriptions including changes in lifestyle, diet, exercise, and nutraceutical supplementation	Diet and physical activity tracker	2 year	No
Secondary	Compliance/adherence with pharmaceutical prescriptions using a medication adherence questionnaire	MMAQ	2 year	No
Secondary	Adverse Events		2 year	Yes